Improving Cardiovascular Health in Veterans with PTSD by Treating Trauma-RelatedNightmares With NightWare

Va Eastern Colorado Health Care System, Aurora CO

Investigators

Abstract

Posttraumatic stress disorder (PTSD) is associated with profound health consequences in Veterans, including cardiovascular disease (CVD), the leading cause of death in adults in the United States. Trauma-related nightmares, a hallmark of PTSD, are a debilitating symptom that can lead to sleep disturbances (e.g., insomnia) and other sequela that ultimately cause clinically significant impairments in functioning. [Recently, nightmares were reported to be an independent predictor of CVD in Veterans, for reasons that are unclear.] Poor sleep is associated with increased CVD risk, possibly by impairing vascular function (i.e., increased large elastic arterial stiffening, endothelial dysfunction) and autonomic nervous system function (e.g., reduced cardiovagal baroreflex sensitivity [cBRS] and heart rate variability [HRV]), risk factors for CVD that are present in individuals with PTSD. Nightmare-related sleep disturbances are often resistant to first-line treatment (e.g., psychotherapy, pharmacological), and even with improvements, residual nightmares and sleep disturbances often persist that still meet clinical significance. Moreover, implementation barriers (e.g., access, lack of trained providers) exist that prevent reaching and engagement of individuals to treatments, and there is poor adherence to psychotherapeutic interventions. As such, there is a need to implement interventions and/or complementary approaches that may appeal to Veterans experiencing PTSD-related nightmares who are looking for alternatives. In this regard, NightWare (NW) digital therapeutic is a novel smart watch application that was recently granted Breakthrough Device designation by the FDA for the treatment of nightmares in adults with PTSD. It uses the wearer’s biometric data (i.e., heart rate, body movement and position) to distinguish normal and distressed sleep and send vibrotactile feedback to the watch to interrupt nightmares. Preliminary evidence demonstrated an improvement in subjective sleep quality after 30-days of NW compared with a sham condition (i.e., no vibrotactile feedback). [However, it is unknown whether NW improves sleep quality in Veterans with PTSD with co-morbid medical conditions such as obstructive sleep apnea (OSA) or in those using medications (e.g., prazosin) to treat nightmares related to PTSD. It is also unknown if the effects of NW on sleep are similar in male and female Veterans, or whether improvements in sleep with NW result in improvements in objective sleep (i.e., sleep physiology) or cardiovascular health. In this context, the Proof-of- Concept phase will determine if 8 weeks of NW improves subjective sleep in Veterans with PTSD-related nightmares, including those with OSA and/or taking medications to treat PTSD related nightmares (e.g., prazosin).] The change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 8 weeks will be measured. Additional goals will evaluate if there are potential sex differences in the response patterns to NW. If the proof-of-concept phase supports our hypothesis that NW significantly improves subjective sleep without a significant increase in acute suicide risk, we will proceed to a larger RCT to determine whether improvements in sleep over 24-weeks of NW are associated with improvements in cardiovascular health. [The change in PSQI, physiological sleep metrics, endothelial function (i.e., brachial artery flow-mediated dilation; primary outcome), large elastic artery stiffness (i.e., carotid-femoral pulse wave velocity) and autonomic function (i.e., cBRS and HRV) indices from baseline to 8 week and the end of a 24-week NW and sham intervention will be measured.] An exploratory aim will acquire mechanistic insight by which NW improves vascular and autonomic function, specifically, related to oxidative stress, inflammation and mitochondrial function. The proposed research is a high priority topic of the Veterans Affairs, as PTSD affects 11-23% of Veterans in a given year. The research is highly innovative and if successful will lead to significant advances in the healthcare of Veterans, particularly as it relates to the treatment of PTSD-related nightmares.